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Job Description

USBU Ethics & Compliance Advisory Lead, Medical Affairs, Patient and Market Access and Public Affairs

Takeda Pharmaceutical

Lexington, MA or Cambridge, MA

About the role:

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as the USBU Ethics & Compliance – Advisory Lead, Medical Affairs, Patient and Market Access and Public Affairs at the Director level in our Lexington, MA or Cambridge, MA office.

As the USBU Ethics & Compliance – Advisory Lead, Medical Affairs, Patient and Market Access and Public Affairs working on the Ethics & Compliance team, reporting into the Head USBU Ethics & Compliance – Advisory, Medical Affairs, Patient and Market Access and Public Affairs, you will be empowered to lead implementation of E&C strategy for USBU by influencing senior management and other stakeholders to adhere to existing ethics & compliance principles and change behavior to new trends that Takeda establishes as best practice.

How you will contribute:

• Ethics & Compliance (E&C) will respond rapidly to changing environment and business needs, it is close to the market, and encourages ethical behavior in line with Takeda's values. By working in an agile manner E&C ensures the balance between stable structures, governance, processes and systems, and dynamic approaches to delivering innovative solutions to appropriately manage our risks.

• E&C commits to act as a role model for Takeda's values, ethics and values-based decision making, fostering this mindset in clients, partners and team

• Enable the organization to take decisions which are ethical and in line with our priorities of Patient, Trust, Reputation, and Business

• Collaborate across all E&C teams and partner with stakeholders in BU / BF to embed ethics and compliance as part of the way everyone works at Takeda

• Maintains and further strengthens business expertise and nurtures cross functional relationships to enable a proactive, holistic, and cross functional approach to risk identification.

• Works closely with senior leaders and cross functional partners to align on, and implement, ethics & compliance controls to proactively manage identified risks.

• Develops programs that empower leaders to seamlessly integrate ethics & compliance principles into their direction to, and leadership of, their teams.

• Provide Ethics & Compliance guidance related to strategic activities, such as brand planning, Incentive Compensation structures, and organizational design.

• Thinks beyond his/her assigned therapeutic area to anticipate the potential impact of his/her advice on other areas of the company and proactively collaborates and communicates with the relevant stakeholders to manage this impact.

• Demonstrates leadership within the USBU E&C organization, such as informally mentoring other team members and proactively educating other team members on relevant topics.

• Provide leadership and guidance to senior management, sales force and home office employees/contractors, and affiliates on interpretation of Code of Conduct, Compliance Policies, and relevant SOPs, guidance documents, and other E&C program requirements.

• Deliver high-impact presentations to promote awareness and adherence to Ethics & Compliance principles.

• Create and manage the content, logistics, and execution of various Ethics & Compliance communication initiatives.

• Develop materials for USBU Compliance Committee meetings including external benchmarking, internal compliance metrics – dashboards, and compliance program vision. Present to USBU President and Executive staff at USBU Compliance Committee meetings where required.

• Create programs for new ways to increase alignment with, Ethics & Compliance principles and Takeda Values through visibility and engagement with field based resources and other stakeholders

• Evaluate potential company activities consistent with company process (or manage team members responsible for this review), such as Patient Services requests, market access initiatives, fair market value requests, medical education, medical affairs guidance, HCP and Patient engagement and potential conflicts of interest.

• Periodically review and adjust policies and procedures to align with current Takeda Legal feedback as well as Compliance team input

• Identify and analyze external trends and drive into organization where needed.

• Perform periodic reviews of US & USBU Policies and Procedures to ensure they are consistent with Takeda Values, OIG regulatory guidance, PhRMA Code requirements and other applicable laws, regulations and internal policies and procedures

• External facing - Drive USBU Advisory engagement with evolving Ethics & Compliance trends (PhRMA, OIG, DOJ)

• Negotiate to create solutions in harmony with leadership and business needs.

• Lead, develop and implement live training programs and strategies designed to support current and planned USBU business models (E.g. – Patient Services, Medical Affairs, Public Affairs training)

• Partner with the business as well as any third-party vendor to live monitor USBU business unit activities, such as field rides, speaker programs and advisory boards.

• Research and respond to compliance hotline/helpline questions on an as-needed basis

Minimum Requirements/Qualifications:

• Bachelor's degree required; JD or relevant advanced degree preferred

• 10+ years of legal, compliance or commercial experience, of which at least 8 years in the healthcare or pharmaceutical industry.

• Strong understanding of state and federal health care laws/regulations

• Extensive experience with laws, regulations and industry guidance that affect the pharmaceutical industry including, but not limited to, OIG and PhRMA guidelines, healthcare standard operating procedures, anti-bribery laws, and state price reporting statute

• Respected expert and advisor to senior management of the BU who influences and drives the Ethics & Compliance agenda for the BU

• Exceptional skills to transform ideas into conversations and materials that resonate (presentations, written documents, email, etc.)

• Consistently demonstrates the ability to deliver results both through self and others

• Able to work and deliver on deadlines while managing multiple projects and priorities effectively

• Works cross-functionally / collaborates / manages matrix - Strong leadership skills, including the ability to lead change efforts through effective communication and persuasion

• Strong customer service skills and ability to demonstrate executive presence while interacting with all levels of management and stakeholders.

• Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Flexible Work Paths

• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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